BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINPREP 5000 PROCESSOR

    MDR report key: 4873872 · Received June 25, 2015

    Report

    Report Number
    1222780-2015-00116
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 25, 2015
    Manufacturer
    HOLOGIC INC.
    Product Code
    MKQ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) INITIALLY REPORTED THEIR THINPREP 5000 PROCESSOR FAILED TO READ THE BARCODE AND REQUESTED SERVICE FROM HOLOGIC INC. HOLOGIC DISPATCHED A FIELD SERVICE ENGINEER (FSE) TO INVESTIGATE THE INCIDENT. THE FSE DETERMINED THE INSTRUMENT MISMATCHED THE SLIDE AND VIAL ID. THERE WAS NO DELAY IN PATIENT DIAGNOSIS, NO MISDIAGNOSIS AND THE PATIENT WAS NOT RECALLED AS A RESULT OF THIS INCIDENT. THE SAMPLE WAS REPROCESSED WITH THE CORRECT SAMPLE IDENTIFIER ETCHED ON THE SLIDE. THIS IS CONSIDERED A REPORTABLE EVENT SINCE THE THINPREP 5000 PROCESSOR DID NOT PERFORM AS INTENDED AND THIS COULD POTENTIALLY LEAD TO A MISDIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410761 THINPREP 5000 PROCESSOR MKQ HOLOGIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other